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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-11-27 to 1990-12-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. An updated OECD guideline from 2002 is available; changes do not affect the reliability of this study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
84/449/EEC
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)
EC Number:
407-410-2
EC Name:
4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)
Molecular formula:
C28H40O8
IUPAC Name:
2-[({5-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-8-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid; 2-[({8-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-4-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): TCD-Emulgator
- Substance type: White solid
- Physical state: Solid
- Purity test date: 1990-04-26
- Lot/batch No.: 90003
- Expiration date of the lot/batch: 1992-01-08
- Storage condition of test material: At room temperature and in darkness
- pH: 5.0 (1 % in H2O)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, UK
- Age at study initiation: No data
- Weight at study initiation: 3.5, 3.2, and 3.6 kg, all female
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet "Ssniff K 4", approx. 100-120 g per animal and day (fed in the morning)
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): Approx. 50 %
- Air changes (per hr): Approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12 (illumination from 6 to 18 hrs CET)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: semiocclusive dressing (Fixomull-Stretch Klebevlies, Beiersdorf no. 2293)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water
- Time after start of exposure: 4 h

SCORING SYSTEM:
According to DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
No other effects.

Any other information on results incl. tables

Skin irritant effects of the TCD-emulsifier:

Animal No.

Body weight

[kg]

Sex

Draize grade after

Irrit. index

1 h

24 h

48 h

72 h

7 d

14 d

e

o

e

o

e

o

e

o

e

o

e

o

e

o

L4

3.5

Female

0

0

0

0

0

0

0

0

0

0

-

-

0.0

0.0

L6

3.2

Female

0

0

0

0

0

0

0

0

0

0

-

-

0.0

0.0

K23

3.6

Female

0

0

0

0

0

0

0

0

0

0

-

-

0.0

0.0

e: erythema and eschar formation

o: oedema formation

-: not examined

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Irritant and/or corrosive effects of TCD-emulsifier were tested according to OECD uideline 404 and EU Method B.4. The test substance is not irritating to rabbit skin.
Executive summary:

In a primary dermal irritation study according to OECD guideline 404 and EU method B.4, adult albino rabbits (strain: HC:NZW) (3 female animals) were dermally exposed to 500 mg TCD-emulsifier in water for 4 hours, administered to 6 cm² at dorso-lateral areas of the animals' trunk. Animals then were observed for 7 days. Irritation was scored by the method of DRAIZE.

No irritation occurred. Based on the study results, TCD-emulsifier is not classified according to CLP Annex I as a dermal irritant.